Colon

61 - Outcomes of Vedolizumab Treatment in Patients With Immune Checkpoint Inhibitor-Induced Diarrhea and Colitis: A Multi-Center Study

Wednesday, October 10
9:30 AM - 9:40 AM
Location: Terrace Ballroom 4 (level 400)

Category: Colon
Hamzah Abu-Sbeih, MD1, Faisal S. Ali, MD2, Dana Alsaadi, MD3, Joseph Jennings, MD3, Wenyi Luo, MD1, Zimu Gong, MD1, David Richards, MD1, Aline Charabaty, MD4, Yinghong Wang, MD1
1University of Texas MD Anderson Cancer Center, Houston, TX; 2Presence Saint Joseph Hospital, Chicago, IL; 3Georgetown University Hospital, Washington, DC; 4MedStar Georgetown University Hospital, Washington, DC

Introduction: Immune mediated diarrhea and colitis (IMDC) can limit immune checkpoint inhibitor (ICPI) treatment, which is an efficacious treatment for advanced malignancies. Given the immune mediated mechanism of this toxicity, steroids and infliximab are commonly used. These agents induce systemic immunosuppression with its associated morbidity. We aimed to assess clinical outcomes of vedolizumab (a gut-targeted anti-integrin agent) as an alternative treatment for IMDC.

Methods: This is a retrospective case series of adults who had IMDC and received vedolizumab from 12/2016 to 4/2018 from MD Anderson Cancer Center and Medstar-Georgetown University Center. All patients had IMDC that is refractory to steroids and/or infliximab.

Results: Total of 28 patients were included; 20 males (71%), 25 Caucasians (89%) with mean age of 63 years. The most common malignancy was melanoma in 7 patients (25%). According to ICPI regimen, 8 patients (29%) received anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4), 12 (43%) programmed death protein-1 or its ligand (PD-1/L-1) and 8 (29%) combination therapy. Median time from ICPI to IMDC onset was 10 weeks (IQR 1-70). Fifteen patients (54%) had grade 2 and 13 (46%) had grade 3 or 4 IMDC. Diagnostic evaluations for IMDCare shown in Table 1. Mucosal ulceration was present in 8 patients (29%), whereas non-ulcerative inflammation was present 13 (46%). All of our patients had features of active histological inflammation; 14 (50%) had features of chronicity, and 10 (36%) had features of microscopic colitis. The treatment and outcomes of IMDC are shown in Table 2. Mean duration of steroid treatment was 96 days (SD 74). Seven patients received infliximab in addition to steroids and were refractory to it. Median number of vedolizumab infusions was 3 (IQR 1-4) with a dose of 300 mg. Mean duration of follow-up in our study was 15 months. Twenty four patients (86%) achieved and sustained clinical remission. Repeat endoscopic evaluation was performed in 17 patients. Endoscopic remission was attained in 7 (54%) of the 13 patients who had abnormal endoscopic findings initially with 5/17 (29) patients reaching histological remission as well. Table 3 lists the characteristics of patients who had clinical remission. In our cohort, only 1 patient developed skin rash and 1 had joint pain.

Discussion: Vedolizumab can be appropriate for the treatment of steroid refractory IMDC, with favorable outcomes and good safety profile.


Disclosures:
Hamzah Abu-Sbeih indicated no relevant financial relationships.
Faisal Ali indicated no relevant financial relationships.
Dana Alsaadi indicated no relevant financial relationships.
Joseph Jennings indicated no relevant financial relationships.
Wenyi Luo indicated no relevant financial relationships.
Zimu Gong indicated no relevant financial relationships.
David Richards indicated no relevant financial relationships.
Aline Charabaty: Takeda – Advisory Committee/Board Member, Speaker's Bureau.
Yinghong Wang indicated no relevant financial relationships.

Hamzah Abu-Sbeih

Research Fellow
University of Texas MD Anderson Cancer Center
Houston, Texas

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